Daily Pharma News - 25 September 2026

CDSCO: painkillers and antibiotics only on prescription (INDIA)

India's drug regulator issued a circular on 21 September directing that NSAIDs (painkillers) and antibiotics be sold only against a valid prescription. The move cites three risks: chronic kidney disease from indiscriminate NSAID use, adverse drug reactions, and the growing threat of antimicrobial resistance (AMR). For pharmacy students, this is stewardship in action — the pharmacist at the counter is the last checkpoint before a drug reaches the patient.

CDSCO eases path for generic lenacapavir, the landmark HIV drug (INDIA)

CDSCO has waived local Phase III trials and bioequivalence studies for generic versions of lenacapavir — the long-acting capsid-inhibitor HIV drug dosed just twice a year — on grounds of unmet medical need. Indian manufacturers Emcure, Dr Reddy's and Hetero are now racing to launch. Faster generic entry could transform HIV prevention and treatment access across low- and middle-income countries.

CDSCO forms AI expert committee for drug regulation (INDIA)

The Drugs Controller General of India (DCGI) announced at the CII Pharma Summit that an expert committee will be formed to frame norms for evaluating artificial intelligence in drug regulation. As AI enters drug discovery, manufacturing and pharmacovigilance, regulators are now building the rulebook for how such tools get assessed.

Karnataka FDA busts fake-drug racket, cancels 16 licences (SOUTH INDIA)

In a major enforcement action, fake vials carrying QR codes were found relabelled as imported brands; 16 licences were cancelled and 8 suspended. A sharp reminder for every future pharmacist: drug authentication and supply-chain integrity start with sourcing only from verified, licensed distributors.

China NMPA clears IND for novel masked HER2xCD3 T-cell engager (CHINA)

China's NMPA has cleared the investigational new drug application for Adagene's ADG138 — a novel double-masked bispecific T-cell engager targeting HER2 and CD3 — which now heads to first-in-human trials in advanced solid tumours. The "masked" design is meant to limit off-tumour toxicity, one of the biggest challenges in T-cell engager therapy.

Russia opens antitrust cases over early generic Eliquis launches (RUSSIA)

Russian authorities have opened antitrust cases against Teva and Grotex for launching generic versions of apixaban (Eliquis) before Pfizer's patent expires. The dispute is a textbook patent-linkage battle — and a lesson in how generic launch strategy collides with originator patent rights.

FDA approves belzutifan plus lenvatinib for advanced kidney cancer (WORLD)

The US FDA has approved belzutifan — a HIF-2α inhibitor — in combination with lenvatinib for adults with advanced clear-cell renal cell carcinoma following immunotherapy. It gives clinicians a new post-immunotherapy option for advanced kidney cancer.

Conclusion

Today's news moves on three fronts at once: tighter stewardship (CDSCO's prescription-only push, the fake-drug crackdown), faster access (lenacapavir generics, AI regulatory frameworks), and therapeutic frontiers (masked T-cell engagers, HIF-2α combinations). The common thread for pharmacy students: the pharmacist's role keeps expanding — from dispenser to gatekeeper, whether that means enforcing prescription-only sales, spotting counterfeits, or counselling patients on tomorrow's biologics.

References

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